Chronic Kidney FailureNBSAFHPNCT06165211
Nature-Based Sound Application For Hemodialysis Patients
A study testing Nature sound listening and Routine care in people with Chronic Kidney Failure and Hemodialysis Patients, run by Necmiye ÇÖMLEKÇİ at 1 site in Turkey (Türkiye).
Trial summary
Chronic renal failure is one of the most common chronic diseases in the world and in our country. Hemodialysis is the most commonly used treatment method in the treatment of chronic renal failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Failure, Hemodialysis Patients, Fatigue
- What is being tested?
- Nature sound listening and Routine care
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2022to 20 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be receiving hemodialysis treatment for at least 6 months,
- Being over 18 years old,
- Not having a hearing and speaking disability,
- Not have a cognitive disability.
Who cannot join
- Receiving hemodialysis treatment for less than 6 months,
- Being under the age of 18,
- Hearing and speech impairment,
- Having a cognitive disability.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Nature-Based Sound Application on Fatigue and Patient Comfort in Hemodialysis Patients
Chronic renal failure is one of the most common chronic diseases in the world and in our country. Hemodialysis is the most commonly used treatment method in the treatment of chronic renal failure. In addition to its important benefits, hemodialysis treatment causes many problems such as fatigue, bone and joint pain, insomnia, mood disorders, sexual problems, paresthesia and nausea. In addition, patient comfort is adversely affected due to physical, psychosocial and environmental problems in hemodialysis patients. Elimination of symptoms in hemodialysis patients and ensuring patient comfort are important components of quality nursing care. For this purpose, it is reported that non-pharmacological evidence-based approaches such as listening to music, yoga, and exercise are used in the literature. Although there are studies examining the effectiveness of listening to music, the number of studies examining the effectiveness of nature-based sounds in hemodialysis patients is quite limited. It is known that sounds such as bird, ocean, water, wind sound have beneficial effects on human health in terms of physiological and psychosocial aspects. This project is to determine the effect of listening to nature sounds during hemodialysis treatment on fatigue and patient comfort.
Type of Study: The project was planned as a randomized controlled experimental study.
Read more
Population and Sample: The population of the study consists of patients who are treated in the Hemodialysis Unit of Bartin State Hospital. The sample was taken as d=0.80 power=0.90, α=0.05 and β=0.20, taking into account the data obtained from a similar study, and it was calculated as 30 patients in the intervention group and 30 patients in the control group, in total 60 patients.
Inclusion criteria for the study:
- To be receiving hemodialysis treatment for at least 6 months,
- Being over 18 years old,
- Not having a hearing and speaking disability,
- Not have a cognitive disability.
Exclusion criteria from the study:
- Receiving hemodialysis treatment for less than 6 months,
- Do not listen to the nature-based audio application for 30 minutes
- Being under the age of 18,
- Hearing and speech impairment,
- Having a cognitive disability.
Read the detailed description
Data Collection Tools: Data will be collected using the Descriptive Information Form, Piper Fatigue Scale and Hemodialysis Patients Comfort Scale.
Descriptive Information Form: In this form, there are 15 questions created in line with the literature. It consists of two sections containing socio-demographic characteristics and disease information.
Piper Fatigue Scale (PFA): Piper et al. It was developed by in 1998. The scale consists of a total of 4 sub-dimensions and 22 items: behavioral sub-dimension (6 items), affective sub-dimension (5 items), emotional sub-dimension (5 items) and cognitive sub-dimension (6 items). Subscale scores and total fatigue scores are calculated using these 22 items. The other 5 items are used to calculate the subscales or total fatigue score. There are three open-ended questions to indicate the cause of fatigue. To calculate the score of the scale, the average score obtained from the scale is calculated by adding up all the scores of the 22 items and dividing by the number of items.
Hemodialysis Comfort Scale (HDCS): Hemodialysis Comfort Scale Orak et al. It was developed to determine the comfort levels of hemodialysis patients. The scale consists of a total of 9 items and two subscales: relaxation and coping. The total score evaluation of the scale and its sub-dimensions is determined by calculating the average score. Cronbach's alpha value of the scale was found to be 0.87.
Data Collection Process: The researcher will collect data in Bartin State Hospital Hemodialysis Unit and fill out the surveys using the interview method. while the patients are during the dialysis session in an average of 30-45 minutes. After the patients registered to the dialysis center are randomized by block randomization method as intervention and control groups, the Patient Diagnosis Form and pre-test (Piper Fatigue Scale and Hemodialysis Comfort Scale) will be applied to the patients before the hemodialysis session. Afterwards, during hemodialysis, listen with an Mp3 player and headphones (to minimize the effect of surrounding noise) for 30 minutes. Nature sounds will be played. After the hemodialysis session is completed, the patients will be given a posttest (Piper Fatigue Scale and Hemodialysis Comfort Scale) by the researcher.
- Being tested
- Nature sound listening, Routine care
- Medical subject headings
- Kidney Failure, Chronic, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nature sound listeningOther
The intervention group listened to nature sounds for 30 minutes during hemodialysis. Nature sounds consisting of bird, wind and tree sounds will be played.
Routine careOther
Patients will watch the program they want on the bedside TV during hemodialysis.
| Study group | Role | What they receive |
|---|---|---|
| Nature Sound Group | Experimental | During hemodialysis, 30 minutes with an Mp3 player and headphones (to minimize the effect of surrounding noise). Nature sounds consisting of bird, wind and tree sounds will be played. Receives: Other: Nature sound listening |
| Routine Care | Placebo comparator | Patients will watch the program they want on the bedside TV during hemodialysis. Receives: Other: Routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Piper Fatigue Scale Score
The scale consists of a total of 4 sub-dimensions and 22 items, including the behavioral sub-dimension (6 items), the affective sub-dimension (5 items), the sensory sub-dimension (5 items), and the cognitive sub-dimension (6 items). Subscale scores and total fatigue scores are calculated using these 22 items. The other 5 items are used to calculate the subscales or the total fatigue score. There are three open-ended questions to indicate the reason for fatigue. In order to calculate the score of the scale, the average score obtained from the scale is calculated by adding all the scores of 22 items and dividing them by the number of items.
Measured: pre-intervention
Hemodialysis Comfort Scale Score
The scale consists of a total of 9 items and two sub-dimensions: relaxation and overcoming. The total score evaluation of the scale and its sub-dimensions is determined by calculating the average score.
Measured: pre-intervention
Secondary outcomes (2)
Piper Fatigue Scale Score
The scale consists of a total of 4 sub-dimensions and 22 items, including the behavioral sub-dimension (6 items), the affective sub-dimension (5 items), the sensory sub-dimension (5 items), and the cognitive sub-dimension (6 items). Subscale scores and total fatigue scores are calculated using these 22 items. The other 5 items are used to calculate the subscales or the total fatigue score. There are three open-ended questions to indicate the reason for fatigue. In order to calculate the score of the scale, the average score obtained from the scale is calculated by adding all the scores of 22 items and dividing them by the number of items.
Measured: immediately after the intervention
Hemodialysis Comfort Scale Score
The scale consists of a total of 9 items and two sub-dimensions: relaxation and overcoming. The total score evaluation of the scale and its sub-dimensions is determined by calculating the average score.
Measured: immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start15 Sep 2022
- Primary completion20 Feb 2023
- Study completion20 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Necmiye ÇÖMLEKÇİ
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Sponsor-investigator, Necmiye ÇÖMLEKÇİ, Bartın Unıversity
- Investigators
- Necmiye ÇÖMLEKÇİ, Principal investigator, Bartın Unıversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06165211
- Sponsor's protocol ID
- Bartın Unıversity
- Other IDs
- 1919B012102111
- Acronym
- NBSAFHP
- Status last verified
- Mar 2024
- First submitted
- 30 May 2023
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Research findings will be published with the article. In addition, research data, excluding personal data, will be shared for secondary results.
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nature-Based Sound Application on Fatigue and Patient Comfort in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT06165211
- Acronym / sponsor ID
- NBSAFHP / Bartın Unıversity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Necmiye ÇÖMLEKÇİUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 20 Feb 2023 (actual)
- Study completion
- 20 Feb 2023 (actual)
- First posted
- 11 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic renal failure is one of the most common chronic diseases in the world and in our country. Hemodialysis is the most commonly used treatment method in the treatment of chronic renal failure. In addition to its important benefits, hemodialysis treatment causes many problems such as fatigue, bone and joint pain, insomnia, mood disorders, sexual problems, paresthesia and nausea. In addition, patient comfort is adversely affected due to physical, psychosocial and environmental problems in hemodialysis patients. Elimination of symptoms in hemodialysis patients and ensuring patient comfort are important components of quality nursing care. For this purpose, it is reported that non-pharmacological evidence-based approaches such as listening to music, yoga, and exercise are used in the literature. Although there are studies examining the effectiveness of listening to music, the number of studies examining the effectiveness of nature-based sounds in hemodialysis patients is quite limited. It is known that sounds such as bird, ocean, water, wind sound have beneficial effects on human health in terms of physiological and psychosocial aspects. This project is to determine the effect of listening to nature sounds during hemodialysis treatment on fatigue and patient comfort.
Type of Study: The project was planned as a randomized controlled experimental study.
Population and Sample: The population of the study consists of patients who are treated in the Hemodialysis Unit of Bartin State Hospital. The sample was taken as d=0.80 power=0.90, α=0.05 and β=0.20, taking into account the data obtained from a similar study, and it was calculated as 30 patients in the intervention group and 30 patients in the control group, in total 60 patients.
Inclusion criteria for the study:
- To be receiving hemodialysis treatment for at least 6 months,
- Being over 18 years old,
- Not having a hearing and speaking disability,
- Not have a cognitive disability.
Exclusion criteria from the study:
- Receiving hemodialysis treatment for less than 6 months,
- Do not listen to the nature-based audio application for 30 minutes
- Being under the age of 18,
- Hearing and speech impairment,
- Having a cognitive disability.
Detailed description
Data Collection Tools: Data will be collected using the Descriptive Information Form, Piper Fatigue Scale and Hemodialysis Patients Comfort Scale.
Descriptive Information Form: In this form, there are 15 questions created in line with the literature. It consists of two sections containing socio-demographic characteristics and disease information.
Piper Fatigue Scale (PFA): Piper et al. It was developed by in 1998. The scale consists of a total of 4 sub-dimensions and 22 items: behavioral sub-dimension (6 items), affective sub-dimension (5 items), emotional sub-dimension (5 items) and cognitive sub-dimension (6 items). Subscale scores and total fatigue scores are calculated using these 22 items. The other 5 items are used to calculate the subscales or total fatigue score. There are three open-ended questions to indicate the cause of fatigue. To calculate the score of the scale, the average score obtained from the scale is calculated by adding up all the scores of the 22 items and dividing by the number of items.
Hemodialysis Comfort Scale (HDCS): Hemodialysis Comfort Scale Orak et al. It was developed to determine the comfort levels of hemodialysis patients. The scale consists of a total of 9 items and two subscales: relaxation and coping. The total score evaluation of the scale and its sub-dimensions is determined by calculating the average score. Cronbach's alpha value of the scale was found to be 0.87.
Data Collection Process: The researcher will collect data in Bartin State Hospital Hemodialysis Unit and fill out the surveys using the interview method. while the patients are during the dialysis session in an average of 30-45 minutes. After the patients registered to the dialysis center are randomized by block randomization method as intervention and control groups, the Patient Diagnosis Form and pre-test (Piper Fatigue Scale and Hemodialysis Comfort Scale) will be applied to the patients before the hemodialysis session. Afterwards, during hemodialysis, listen with an Mp3 player and headphones (to minimize the effect of surrounding noise) for 30 minutes. Nature sounds will be played. After the hemodialysis session is completed, the patients will be given a posttest (Piper Fatigue Scale and Hemodialysis Comfort Scale) by the researcher.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nature Sound Group | Experimental | Other: Nature sound listeningDuring hemodialysis, 30 minutes with an Mp3 player and headphones (to minimize the effect of surrounding noise). Nature sounds consisting of bird, wind and tree sounds will be played. |
| Routine Care | Placebo comparator | Other: Routine carePatients will watch the program they want on the bedside TV during hemodialysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- To be receiving hemodialysis treatment for at least 6 months,
- Being over 18 years old,
- Not having a hearing and speaking disability,
- Not have a cognitive disability.
Key exclusion criteria (4 listed)
- Receiving hemodialysis treatment for less than 6 months,
- Being under the age of 18,
- Hearing and speech impairment,
- Having a cognitive disability.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nature sound listeningThe intervention group listened to nature sounds for 30 minutes during hemodialysis. Nature sounds consisting of bird, wind and tree sounds will be played. | Other | Nature Sound Group |
| Routine carePatients will watch the program they want on the bedside TV during hemodialysis. | Other | Routine Care |
Primary outcome
Piper Fatigue Scale Score
Time frame: pre-intervention
The scale consists of a total of 4 sub-dimensions and 22 items, including the behavioral sub-dimension (6 items), the affective sub-dimension (5 items), the sensory sub-dimension (5 items), and the cognitive sub-dimension (6 items). Subscale scores and total fatigue scores are calculated using these 22 items. The other 5 items are used to calculate the subscales or the total fatigue score. There are three open-ended questions to indicate the reason for fatigue. In order to calculate the score of the scale, the average score obtained from the scale is calculated by adding all the scores of 22 items and dividing them by the number of items.
Hemodialysis Comfort Scale Score
Time frame: pre-intervention
The scale consists of a total of 9 items and two sub-dimensions: relaxation and overcoming. The total score evaluation of the scale and its sub-dimensions is determined by calculating the average score.
2 secondary outcomes
Piper Fatigue Scale Score
Time frame: immediately after the intervention
Hemodialysis Comfort Scale Score
Time frame: immediately after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Individual participant dataSharing planned: Yes. Research findings will be published with the article. In addition, research data, excluding personal data, will be shared for secondary results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Necmiye ÇÖMLEKÇİ principal investigator
Bartın Unıversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nature sound listening and Routine care in people with Chronic Kidney Failure and Hemodialysis Patients, run by Necmiye ÇÖMLEKÇİ at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Piper Fatigue Scale Score (time frame: pre-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2024.